MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE Wireguided; colonoscope and accessories, flexible/rigid

Model Number	M00558410
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was attempted to be used in the biliary tract during an endoscopic retrograde cholangiopancreatography (ercp) procedure for stenosis performed on (b)(6) 2026.During the procedure, the balloon burst after reaching a diameter of 15mm.The procedure was completed with another cre wireguided dilatation balloon.There were no patient complications reported as a result of this event.The patients condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of balloon burst block h11: investigation results the device was not returned for analysis despite good faith efforts to obtain product return; therefore, a technical analysis could not be performed.With all available information, boston scientific concludes the reported event of balloon burst could not be confirmed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.The device history record review confirmed that the device met all material, assembly, and performance specifications prior to distribution.A similar complaint review was completed.There were no emerging trends identified that warrant further action.

• Brand Name: CRE Wireguided
• Common Device Name: colonoscope and accessories, flexible/rigid
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Cork Limited; cork business technology park; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50217658
• Report Number: 3005099803-2026-03288
• Device Sequence Number: 10293995
• Product Code: FDT
• UDI-Device Identifier: 08714729339342
• UDI-Public: (01)08714729339342(17)280622(10)37042946
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00558410
• Device Catalogue Number: M00558410
• Device Lot Number: 0037042946
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 07/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 171 LB